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Let us make your process predictive!
Key Pharma Market Aspects
The global market for Pharma is rapidly changing and evolving.
The increasing regulation decreases product profitability
preference for Generics
Cost cutting & budgeting
Increase of purchasing power
high PAI & drug development risks & costs
The complexity & costs of quality administration on top of
production costs are high and increase (IPC, QA, QM).
New production technologies and measurement methods are
available.
The cost of drug production incl. quality plays a
more significant role.
Think Pharma will increase
your production efficiency
Deep understanding of your production process
Quality
Integration of quality into process steps
Reduction of quality overhead costs
Performance
Higher production quality, lower production costs
Costs
In bandwidth, self adjusting production processes
Think Pharma integrates quality into your production:
Quality – by – Design (QbD)*
*based on ICH Q 8, 9, 10, GAMP 5, Annex 20 QM
Pharma Process Management
(Present)
discard
Preliminary
product
Checking
(Laboratory)
approve
IPC
checking
Process
Step 1
Process
Step 2
Rework
Process
Step 1
discard
approve
process
locking
Pharma Process Management
(Present)
discard
checking
approve
Step 3
Step 2
Step 1
discard
checking
approve
Time
Cost
Cost
Time
Cost
discard
checking
approve
Time
process
The Goal for QbD Pharma
Process Management (Future)
Step 1 Step 2 Step 3 Step 4
Step 5 Step 6
Process
Inline testing
adaption
direction
Why a Think Pharma Network?
QbD projects are complex and needs different specific knowledge.
Josteit, Herten & Partner
cGxP Compliance
Quality Management
Additional
NIR-Online
NIR-Measurement
& Controlling
Analytical Methods
TP-Core
Network
Microinnova
Micro structured Systems
Process Development &
Engineering
Specialists
Keynes
Production Design
Production Planning
& Realization
Why a Think Pharma Network?
For You:
A cross-pollinated solution
given by the combined knowledge and
experience of the TP Core Network
Practically founded and proven
process solutions adopted to the
specific needs of the pharmaceutical industry
Benefits of experience from
other closely related industry processes
Short and precise advice, planning,
implementation and qualification
Think Pharma delivers for
QbD-Projects (overview)
Installation planning
Control & measure technology
Micro-process technology
Process design
Basic engineering
Information technology
cGxP compliance
Our understanding of the
pharmaceutical industry needs.
We identified 3 need categories for QbD (key drivers):
C1 Establishing a new production process
C2 Production process change: Up-scaling, outsourcing, standardization
C3 Production process problems; high deficient product
For the 3 categories we identified 3 tool-boxes…:
Toolbox
C1
C2 C3
Knowledge Space Mapping (KS)
X
Design Space Definition (DS)
X
X
Control Space Definition (CS)
X
X
X
The QbD-Toolbox
Project Management: CATADIA
Knowledge Space Mapping (KS)
Customer objective definition
QbD relevant development/organisational
interfaces
Development Knowledge Base:
Chemical/physical identities
Product composition and formulation
Production processes & technology
Reference model/ benchmarking
R & D process
Analytical & process assessment (actual)
Process key data
Knowledge Space Mapping Report
Toolbox 1
Client SP
CATADIA
NO KE MI
Extract
SP = Special Partner
JH&P = Josteit, Herten & Partner
NO = NIR-Online
KE = Keynes
MI = Microinnova
The QbD-Toolbox
Toolbox 2
Design Space Definition (DS)
Risk analysis
Determination of Critical Process Parameters
(CPP) and Critical Control Points (CCP)
Definition of the verification of CCP as well as
development of the corrective actions
Design Specification
Client SP
CATADIA
NO KE MI
The QbD-Toolbox
Toolbox 3
Control Space Definition (CS)
Client SP
Development of approximate specified scenario
Conservative (PO) or Radical approach (QbD)
Qualification/Validation
Composition/Conception
Technical Design, …
Development
Piloting
Realisation
Reorganisation
Training
Client Final Acceptance
CATADIA
NO KE MI
ALL
TP proven industry values
Competences
Process
Plant
Measurement
Validation …
Experiences
Fields
Chemical, Petro, Food, Pharma, Automotive, Bio Fuels, …
Content
Automation, R&D, CGxP, Planning, Construction,
Micro Reactor Technologies, …, Project Management
Clients
BASF, Roche, Novartis, Grünenthal, ADM, Bayer,
Schering, Degussa, Umicore, IMA, …
Contact
You can reach us for more information and detail discussion:
Dieter E. Herten
Geschäftsführer
CATADIA Consulting GmbH
Jentgesallee 11
47799 Krefeld
Phone: +49-21 51-15 18 00-1
E-Mail: [email protected]
WEB: www.think-pharma.de or www.quality-by-design.de
QbD Easy Example : My best Coffee quality
Coffee Quality 1
Coffee Quality 2
Coffee
Quality
not
accepted
Coffee Quality 3
The mill knows exactly
My QbD Coffee Mill
what Coffee quality I
want (consistency, taste,
temperature, cup filling quantity)
This coffee is always
perfect as I like it.